Unique ID issued by UMIN | UMIN000008093 |
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Receipt number | R000008987 |
Scientific Title | Phase 1 Clinical Trial of intra-thoracic administration of Zoredronic Acid in Subjects with Unresectable Malignant Pleural Mesothelioma |
Date of disclosure of the study information | 2012/06/04 |
Last modified on | 2019/01/31 17:08:01 |
Phase 1 Clinical Trial of intra-thoracic administration of Zoredronic Acid in Subjects with Unresectable Malignant Pleural Mesothelioma
Phase 1 Trial of Zoredronic Acid in Malignant Pleural Mesothelioma
Phase 1 Clinical Trial of intra-thoracic administration of Zoredronic Acid in Subjects with Unresectable Malignant Pleural Mesothelioma
Phase 1 Trial of Zoredronic Acid in Malignant Pleural Mesothelioma
Japan |
Malignant Pleural Mesothelioma
Pneumology | Hematology and clinical oncology |
Malignancy
NO
o establish the safety of intra-thoracic administration of Zoredronic Acid and to guide decision making for the effective dose
Safety,Efficacy
Exploratory
Explanatory
Phase I
Evaluation of the incidence of the adverse effect and dose limiting dose(DLT)
Anti-tumor effect (Response to the treatment)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Initial dose of 0.4mg of Zoredronic acid will be administered by injection into thoracic cavity. Thereafter, patients will be observed for at least two weeks to evaluate the adverse effects. Transition to the next cohort will be decided following the evaluation of the development of DLT. The dose will be gradually increased every three subjects from 0.4mg to 1mg, 4mg, 8mg, 12mg and 16mg respectively.Repeat injections for the same patient at the same dose are acceptable.
20 | years-old | <= |
80 | years-old | > |
Male and Female
Patients with histologically or
cytologically documented malignant
pleural mesothelioma
Unresectable case(including recurrent case of post-operation)
Patients refractory to chemotherapy,
or those relapsed after therapies.
Patients who reject chemotherapy will
be also included.
ECOG Performance status 0 to 2
Life expectancy must be longer than 3 month from
the entry.
Patients who are free of marked
failure of major organ function, more
over the following criteria must be
satisfied in laboratory tests. WBC >=3000/mm3, neutrophil>=1500 /mm3, Hgb>=
8.0 g/dl, Plt >=100.000 /mm3, AST/ALT<=
100 IU/L, T-Bil<=1.5 mg/dl, Cre<=1.5
mg/dl Ccr >=60 ml/min , PaO2>= 60 mmHg or>=90% by pulse oxymetry
Informed consent must be obtained
Patient with active multiple primary
cancer (synchronous multiple primary
cancer and invasive cancer of other
organs)
Patient with symptomatic brain
metastasis requiring any treatments
Patient underwent thoracic irradiation
therapy or pleurodesis (within a month).
Patient with interstitial pneumonia,
confirmed by clinical examination or
by chest CT scan
Patients with history of myocardial
infarction (MI) in recent 6 month, or
those with any risk of MI recurrence.
Patient with other severe medical
complications.
Patient with history of drug-related
allergy to zoredronic acid or other
bisphosphonate or those with AEs over
Grade 3 in CTCAE.
Patient with stomatognathic disease
(pulpitis, gingivitis,etc) requiring
invasive (surgical) treatment.
Patient who received chemotherapy for
mesothelioma, or those participated
other clinical trial for unapproved
drug with in a month.
Difficult to participate in the trial
because of psychiatric disorder or
psychiatric symptoms
Pregnant or lactating woman.
Ineligible to the trial based on
decision of an investigator, such as
poor compliance to follow up in the
clinical course.
18
1st name | |
Middle name | |
Last name | Yuji Tada |
Chiba University Hospital
Department of Respirology
260-5670 1-8-1 Inohana Chuo-ku Chiba, Chiba prefecture, Japan
81432227171
ytada@faculty.chiba-u.jp
1st name | |
Middle name | |
Last name | Yuji Tada |
Chiba University Hospital
Department of Respirology
260-5670 1-8-1 Inohana Chuo-ku Chiba, Chiba prefecture, Japan
81432227171
http://www.m.chiba-u.ac.jp/class/respir/index.html
ytada25@yahoo.co.jp
Chiba University Hospital
none
Self funding
Japan
Chiba Cancer Center
Toho University Omori Medical Center
Tokyo Women's Medical University Yachiyo Medical Center
none
NO
千葉大学医学部附属病院(千葉県) Chiba University Hospital
2012 | Year | 06 | Month | 04 | Day |
Unpublished
Completed
2012 | Year | 03 | Month | 26 | Day |
2012 | Year | 06 | Month | 01 | Day |
2018 | Year | 12 | Month | 24 | Day |
2018 | Year | 12 | Month | 24 | Day |
2018 | Year | 12 | Month | 24 | Day |
2018 | Year | 12 | Month | 24 | Day |
2012 | Year | 06 | Month | 04 | Day |
2019 | Year | 01 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008987
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